The journal Heart Rhythm will not retract a study published last month that linked St. Jude Medical’s Riata and Riata ST defibrillator leads to 22 deaths that were the result of high-voltage failures of the leads. St. Jude, which had sought retraction of the Heart Journal study, has maintained that its findings are biased and inaccurate.

Background: Riata Defibrillator Lead Recall

A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via an implantable defibrillator. In December 2010, St. Jude stopped selling the Riata and Riata ST wires and warned doctors to stop using them because of reports that the wires could poke through their insulation. This defect could cause the defibrillator to emit unnecessary shocks to the heart, or cause the device to fail to send an electrical impulse to the organ when needed. At the time, the company reported to doctors that the wires had a 0.47% rate of “insulation abrasion” after 9 years of use. As we reported previously, St. Jude launched an official recall of the Riata wires in December 2011, and revealed that two patients had died during procedures to remove the leads. An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S.

The Riata Lead Study in Heart Rhythm

The Heart Rhythm study, conducted by prominent cardiologist Dr. Robert Hauser, found that the Riata leads were associated with higher death and failure rates than Medtronic’s Sprint Quattro defibrillator leads. Hauser said the Riata lead failures appeared to be caused by insulation defects that resulted in short-circuiting between high-voltage components. According to Hauser, a search of the U.S. Food and Drug Administration (FDA) Manufacturers and User Facility Device Experience (MAUDE) database indicated that this problem with Riata and Riata ST leads had caused 22 deaths, more than were associated with Medtronic’s Quattro wires. The insulation defects identified by Hauser’s study are not the same problems that prompted the December 2011 Riata recall. In fact, Hauser’s analysis of the FDA database did not identify any deaths from exposed wires.
The Riata Lead Controversy

St. Jude demanded a retraction of the Heart Rhythm study in a statement issued last Friday. According to the company, an analysis of the FDA database it performed using Hauser’s own criteria had produced different results. St. Jude said it found 377 reports of deaths involving Quattro Secure wires, while Hauser reported 62. The company’s analysis of Riata lead events in the database found 74 deaths, while Hauser reported 71. St. Jude said it used the same criteria as Hauser had in performing its analysis.

St. Jude also criticized Hauser’s used of the MAUDE database for his study, asserting that doing so caused his findings to be biased “against manufacturers that more transparently report on device malfunctions” The company claimed that Medtronic reports the least amount of detail regarding adverse events compared with other companies in the industry.

Finally, in an article published in The New York Times over the weekend, officials at St. Jude claimed that its rivals, including Medtronic Inc., had engaged in a “whisper campaign” to discredit its heart devices, and were using the Riata issue to gain market share for their own products.

Medtronic Inc. denied those allegations, and also claimed that its own analysis of the FDA database produced results that echoed those seen in the Heart Rhythm study.

Latest Developments

According to an article appearing in The New York Times today, Heart Rhythm rejected St. Jude’s request that the Riata lead study be retracted. The journal’s editor, Dr. Douglas P. Zipes, said in an interview with the Times that the publication had looked at St. Jude’s complaint and had no plans to retract the article, which had undergone review by experts associated with the journal before its online publication. Zipes also pointed out that the analysis St. Jude released on Friday had not been independently reviewed to determine its accuracy. He has offered the company the opportunity to submit its analysis for review.

What Should Riata Lead Patients Do?

When it recalled the Riata leads in December 2011, St. Jude recommended:

Careful monitoring of internal defibrillator patients with fully intact tubing, as well as those with wires poking through that do not have any observable electrical problems.

Patient with exposed wires and their doctors should weigh the risks of lead extraction and make an informed decision regarding the procedure.

The surgical removal of a defibrillator lead can be dangerous, and cause internal bleeding, a tear in a vein or heart, or death.